CISATRACURIUM OMEGA MULTIDOSE SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CISATRACURIUM (CISATRACURIUM BESYLATE)

Disponible desde:

OMEGA LABORATORIES LIMITED

Código ATC:

M03AC11

Designación común internacional (DCI):

CISATRACURIUM

Dosis:

2MG

formulario farmacéutico:

SOLUTION

Composición:

CISATRACURIUM (CISATRACURIUM BESYLATE) 2MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

10*10ML

tipo de receta:

Prescription

Área terapéutica:

NEUROMUSCULAR BLOCKING AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0133260001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2013-06-28

Ficha técnica

PRODUCT MONOGRAPH
PR
C
ISATRACURIUM
O
MEGA
S
INGLE
D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(5 mL single dose vial)
PR
C
ISATRACURIUM
O
MEGA
M
ULTI
-D
OSE
Cisatracurium Besylate Injection
2 mg/mL cisatracurium
(10 mL multiple dose vial)
NON-DEPOLARIZING SKELETAL NEUROMUSCULAR BLOCKING AGENT
Sterile solution
THIS DRUG SHOULD BE ADMINISTERED ONLY BY ADEQUATELY TRAINED
PROFESSIONALS FAMILIAR
WITH ITS ACTIONS, CHARACTERISTICS, AND HAZARDS.
Omega Laboratories Limited
11 177, Hamon
Montreal, Canada
H3M 3E4
DATE OF PREPARATION
:
June 27, 2013
SUBMISSION CONTROL NO: 138615
Page
2
of
37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................. 3
SUMMARY PRODUCT
INFORMATION....................................................................
3
INDICATIONS AND CLINICAL USE
.........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
.............................................................................
4
ADVERSE REACTIONS
.............................................................................................
10
DRUG INTERACTIONS
.............................................................................................
11
DOSAGE AND ADMINISTRATION
.........................................................................
13
OVERDOSAGE
............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 20
STORAGE AND STABILITY
.....................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
................................................................... 28
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 28
PART II: SCIENTIFIC INFORMATION
...................................